Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov/)
Title: Limited
Competition: Frequent Hemodialysis Network (U01)
Announcement Type
This is a reissue of RFA-DK-03-005 which
was previously released January 15, 2003.
Request For Applications (RFA) Number: RFA-DK-07-503
Catalog of Federal Domestic Assistance Number(s)
93.849
Key Dates
Release Date: August 10, 2007
Letters of Intent Receipt Date: October 2,
2007
Application Receipt Date: October
30, 2007
Peer Review Date: November-December
2007
Council Review Date: January
2008
Earliest Anticipated Start Date: February
1, 2008
Additional Information To Be Available Date
(Url Activation Date): Not applicable
Expiration Date: October 31, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Hundreds of thousands of people with endstage renal failure are alive today because they receive treatment with hemodialysis. While kidney transplantation and peritoneal dialysis are also available to treat kidney failure, in-center hemodialysis remains the predominant form of renal replacement therapy in North America. Despite its dramatic success at saving lives, hemodialysis is far from perfect therapy – more than 20% of hemodialysis patients die each year. Even more troubling, the annual mortality rate has changed little in the past decade, despite some success in achieving evidence-based quality improvements. In addition, morbidity remains high, with frequent complications of heart disease, hypertension, anemia, bone disease, poor nutrition, inflammation, depression and impaired cognitive and physical function. These result in impaired quality of life and contribute to diminished longevity. Observational studies suggest that many of these adverse outcomes may in part be caused by inadequate dose of dialysis. The HEMO study was designed to test the hypothesis that a higher dose of dialysis would enhance dialysis-related survival. This 2 x 2 factorial design, randomized clinical trial compared outcomes of patients treated with eKt/V for urea of 1.45 to those with eKt/V for urea 1.05, and high-flux vs. low-flux dialysis. The results of this study were a surprise to many: there were no significant differences between the two dose groups in mortality, hospitalizations or other secondary endpoints. However negative results from the HEMO trial do not rule out benefits of more intensive therapies extending beyond the limits of conventional three times per week hemodialysis.
Nephrologists have been experimenting with frequent hemodialysis for over 40 years . Since 1998, several studies of more frequent hemodialysis have been published. Among the putative benefits of more frequent hemodialysis at night are improved blood pressure control, anemia and health-related quality of life, with mixed results for changes in left ventricular hypertrophy and mineral metabolism. For frequent short daily hemodialysis, observational studies have found better blood pressure control, but the effects of daily hemodialysis on quality of life, anemia, phosphorus control and nutritional status were inconsistent. A reduction in cardiac left ventricular hypertrophy as assessed by echocardiography was seen, but the relative contribution of reduced extracellular water vs. reduced muscle mass to these estimates is unclear.
Because patient selection factors cannot be ruled out as causative factors in these observational studies, the NIDDK issued an RFA in 2003 for randomized trials of frequent hemodialysis. Based on that RFA, cooperative agreements were awarded to three clinical coordinating centers (UCSF and RRI for short daily dialysis and Wake Forest University for nocturnal dialysis) and one data coordinating center (the Cleveland Clinic).
There are two trials in the FHN. The first is a trial testing the efficacy of short daily diaylsis. A total of 250 ESRD patients receiving in-center HD will be randomized to continue with conventional HD, 3 days per week (control group), or switch to daily HD, 6 days per week (intervention group). Subjects will be treated and followed for 12 months. Two co-primary outcomes are designated: 1) a composite of mortality with the change over 12 months in left ventricular mass, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes.
The second trial is designed to test the efficacy of nocturnal home dialysis. As with the daily trial, a total of 250 dialysis patients are planned for recruitment. First, patients will be selected for home dialysis training. After training they will be randomized to perform routine 3 times per week dialysis at home or 6 times per week nocturnal dialysis. Because of the extra time needed for training, follow-up will be 14 months instead of 12. The primary and secondary outcomes are the same as in the short daily dialysis study.
The objective of this Limited Competition is to continue these trials so that enrollment, follow-up and statistical analysis can be completed.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the Cooperative
Agreement (U01) award mechanism(s).
As an applicant, you will be solely responsible
for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget
concepts. It also uses the non-modular budget format described in the PHS
398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and
the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH U01 is a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Principal Investigator retains the primary responsibility
and dominant role for planning, directing, and executing the proposed project,
with NIH staff being substantially involved as a partner with the Principal
Investigator, as described under the Section VI. 2.
Administrative Requirements, "Cooperative Agreement Terms and Conditions
of Award".
2. Funds Available
The total amount of funding that your agency/IC expects to award through
this announcement;
NIDDK intends to commit approximately $3,200,000 dollars in FY 2008 to fund The Frequent Hemodialysis Network in response to this RFA. An applicant may request a project period of up to 2 years and a budget for total costs up to $800,000 in the first year.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation,
see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
As this FOA is a limited competition opportunity that involves a continuation
of the cooperative agreements supporting the FHN clinical trials, only the current
U01 FHN awardees are eligible to submit applications.
1.B. Eligible Individuals
Individuals from the existing FHN CCs
with the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups
as well as individuals with disabilities are always encouraged to apply
for NIH support.
2. Cost Sharing or Matching
Not Applicable
The most current Grants Policy Statement can be
found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
None
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application instructions are available
at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative agreements.
The D&B number can be obtained by calling (866) 705-5711 or through
the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the
PHS 398 form.
The title and number of this funding opportunity
must be typed on line 2 of the face page of the application form and the
YES box must be checked.
Foreign Organizations Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide
special opportunities for furthering research programs through the use
of unusual talent, resources, populations, or environmental conditions
in other countries that are not readily available in the United States
or that augment existing U.S. resources.
3. Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A). Submission
times N/A.
3.A. Receipt, Review and Anticipated
Start Dates
Letters of Intent Receipt Date: October 2,
2007
Application Receipt Date: October
30, 2007
Peer Review Date: November-December
2007
Council Review Date: January
2008
Earliest Anticipated Start Date: February
1, 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter
of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date
listed at the beginning of this document.
The letter of intent should be sent to:
Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney
Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301)
594-8897
FAX: (301) 480-3505
Email: calvof@niddk.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the research
grant applications found in the PHS 398 instructions for preparing a research
grant application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer
permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies
of the application and all copies of the appendix material must be sent
to:
Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney
Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301)
594-8897
FAX: (301) 480-3505
Email: calvof@niddk.nih.gov
Using the RFA Label: The RFA label available in the PHS 398 application instructions
must be affixed to the bottom of the face page of the application. Type
the RFA number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed
on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR
and responsiveness by the NIDDK. Incomplete and non-responsive applications will not be reviewed.
If the application is not responsive to the RFA,
NIH staff may contact the applicant to determine whether to return the
application to the applicant or submit it for review in competition with
unsolicited applications at the next appropriate NIH review cycle.
The NIH will not accept any application in response
to this funding opportunity that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as
an investigator-initiated application, is to be submitted in response to
a funding opportunity, it is to be prepared as a NEW application. That is,
the application for the funding opportunity must not include an Introduction
describing the changes and improvements made, and the text must not be marked
to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should
be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing continuation award if such costs: are necessary
to conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the
cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new
or competing continuation award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an
award is made for less than the amount anticipated and is inadequate to
cover the pre-award costs incurred. NIH expects the grantee to be fully
aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish
the project objectives in the approved time frame or in any way adversely
affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Plan for Sharing Research Data
The precise content of the data-sharing plan will
vary, depending on the data being collected and how the investigator is
planning to share the data. Applicants who are planning to share data may
wish to describe briefly the expected schedule for data sharing, the format
of the final dataset, the documentation to be provided, whether or not any
analytic tools also will be provided, whether or not a data-sharing agreement
will be required and, if so, a brief description of such an agreement (including
the criteria for deciding who can receive the data and whether or not any
conditions will be placed on their use), and the mode of data sharing (e.g.,
under their own auspices by mailing a disk or posting data on their institutional
or personal website, through a data archive or enclave). Investigators choosing
to share under their own auspices may wish to enter into a data-sharing
agreement. References to data sharing may also be appropriate in other sections
of the application.
Applicants requesting more than $500,000 in
direct costs in any year of the proposed research must include a plan for
sharing research data in their application. The funding organization will
be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
All applicants must include a plan for sharing research
data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include
a description of how final research data will be shared, or explain why
data sharing is not possible.
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (NIH Grants
Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources
will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the administrative
review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review
Information
1. Criteria
Only the review criteria described below will
be considered in the review process.
The following will be considered in making
funding decisions:
2. Review and Selection Process
Applications that are complete and responsive to
the RFA will be evaluated for scientific and technical merit by an appropriate
peer review group convened by NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications
will:
The goals of NIH supported research
are to advance our understanding of biological systems, to improve the
control of disease, and to enhance health. In their written critiques,
reviewers will be asked to comment on each of the following criteria in
order to judge the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals. Each of these criteria will be addressed
and considered in assigning the overall score, weighting them as appropriate
for each application. Note that an application does not need to be strong
in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions
that drive this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does
the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support? Has recruitment and retention in the previous
funding cycle been adequate?
2.A. Additional Review Criteria:
In addition to the above criteria, the following
items will continue to be considered in the determination of scientific
merit and the priority score:
Protection of Human Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate
for the scientific goals of the research will be assessed. Plans for the
recruitment and retention of subjects will also be evaluated (see the Research
Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five
items described under Section F of the PHS Form 398 research grant application
instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research. The priority score
should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score. The presence of a data sharing
plan will be part of the terms and conditions of the award. The funding
organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and
http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should
include a sharing research resources plan addressing how unique research
resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing plan will
be considered by Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications of
the data and resource sharing plans with the awardee before recommending
funding of an application. The final version of the data and resource sharing
plans negotiated by both will become a condition of the award of the grant.
The effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590).
See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH Grants Policy Statement Part
II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by
the grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official
(designated in item 12 on the Application Face Page). If a grantee is not
email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of
the NoA are at the recipient's risk. These costs may be reimbursed only
to the extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award,
see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH
Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated
into the award statement and will be provided to the Principal Investigator
as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of
Award
The following special terms of award are in addition
to, and not in lieu of, otherwise applicable OMB administrative guidelines,
HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92
is applicable when State and local Governments are eligible to apply), and
other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement (U01), an "assistance" mechanism
(rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients' activities
by involvement in and otherwise working jointly with the award recipients
in a partnership role; it is not to assume direction, prime responsibility,
or a dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the awardees for the
project as a whole, although specific tasks and activities may be shared
among the awardees and the NIH as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary
responsibility for the conduct of the clinical trial. This will include
any changes in study protocol that need to be done, coordination of IRB
clearances, oversight of all sub-contracts, quality control, recruitment
of study subjects, analysis of study results and close-out activities.
Awardees will retain custody of and have primary
rights to the data and software developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards,
as described below.
The NIDDK Project Scientist will
assist the Principal Investigator through the Steering Committee
in carrying out the study. The Project Scientist will have substantial
scientific-programmatic involvement in assisting in protocol refinement,
quality control, interim data analysis, final data analysis and interpretation,
preparation of publications, and will provide assistance in coordination
and performance monitoring. The NIDDK Project Scientist will also
serve as a member of the Steering Committee.
Additionally, an agency program official or IC program
director will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
The Steering Committee will be
the principal governing body of the Frequent Hemodialysis Network. Voting
membership on the Steering Committee will consist of the government project
scientist, each of the four principal investigators, and the chair of
the Steering Committee, who will be named by the government. This
Committee will have the primary responsibility for determining the study
protocol, monitoring the conduct of the study, and reviewing data prior
to reporting of study results. It will also be responsible for determining
study policies in such areas as access to participant data, ancillary
studies, publications and presentations, and quality standards.
Each full member will have one vote. Awardee members
of the Steering Committee will be required to accept and implement policies
approved by the Steering Committee.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to arbitration. An Arbitration Panel composed
of three members will be convened. It will have three members: a designee
of the Steering Committee chosen without NIH staff voting, one NIH designee,
and a third designee with expertise in the relevant area who is chosen by
the other two; in the case of individual disagreement, the first member
may be chosen by the individual awardee. This special arbitration procedure
in no way affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the PHS Non-Competing
Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions
from potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Dr. Paul W. Eggers
Program Director for Kidney and Urology Epidemiology
National Institute of Diabetes
and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 615
Bethesda, Maryland 20892-5458
Telephone: (301) 594-8305
FAX (301) 480-3510
Email: eggersp@extra.niddk.nih.gov
2. Peer Review Contacts:
Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney
Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier
service)
Telephone: (301) 594-8897
FAX: (301)
480-3505
Email: calvof@niddk.nih.gov
3. Financial or Grants Management Contacts:
Charlette Kenley
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes,
Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 723
Bethesda, Maryland 20892-5456
Telephone: (301)
594-8847
FAX: (301) 480-9523
E-mail: kenleyc@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and
Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference
to the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risks to the
participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants
and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well
as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor
the plan into the determination of the scientific merit or the priority
score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal
funds and (2) cited publicly and officially by a Federal agency in support
of an action that has the force and effect of law (i.e., a regulation) may
be accessed through FOIA. It is important for applicants to understand the
basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that:
a) all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection
of human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in
the application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit
to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on
or after May 2, 2005. The NIH Public Access Policy applies to all research
grant and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office
for Civil Rights (OCR).
Decisions about applicability and implementation
of the Privacy Rule reside with the researcher and his/her institution.
The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation
Text and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or Progress
report, internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information
necessary for the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas.
This RFA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and
is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients
to provide a smoke-free workplace and discourage the use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any portion of
a facility) in which regular or routine education, library, day care, health
care, or early childhood development services are provided to children.
This is consistent with the PHS mission to protect and advance the physical
and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment
to pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required
for eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based
on a 40 hour week) for two years to the research. For further information,
please see: http://www.lrp.nih.gov.
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NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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